System and method for controlling electronic communications

ABSTRACT

The approved email generation system described is capable of producing email communications between user and customer by using approved email templates and content that have been aligned with customer information regarding access to such content. The approved email template comprises data pulled from a record for a medical inquiry and a window for receiving free text responding to the medical inquiry. Once the approved email has been generated, the content may be verified again for accuracy and validity and the free text may be checked for any unapproved word before being delivered to the customer.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. nonprovisionalpatent application Ser. No. 14/271,134, filed on May 6, 2014, entitledSystem and Method for Controlling Electronic Communications, whichclaims priority to provisional patent application nos. 61/820,029, filedMay 6, 2013 and 61/828,034, filed May 28, 2013, both entitled “Systemand method for controlling electronic communications.” All of theseprovisional and nonprovisional patent applications are herebyincorporated by reference herein for all purposes.

TECHNICAL FIELD

The present application relates generally to systems and methods thatprovide for sending approved content to electronic communicationsrecipients, including methods and systems for building the approvedcontent and generating the approved messages for electroniccommunications such as email.

BACKGROUND

In certain fields, the ability to achieve the efficiencies associatedwith modern electronic communications such as email has been hampered bythe risks (regulatory and otherwise) of sending such electroniccommunications. An example of one field that has been so limited hasbeen the pharmaceutical sales industry, where sales reps typically arerestricted from sending email communications to prescribing doctorsbecause of the enormous risks that can flow from unapproved,uncontrolled messages. For example, a careless rep or other personnelmight send an email to a subscribing doctor suggesting off-label usesfor a drug. This could end up exposing the company employer (e.g., apharmaceutical company) to regulatory penalties or other legalliabilities.

SUMMARY

Embodiments disclosed in the present document provide amachine-implemented method for generating approved emails. The methodcomprises: establishing a controlled content repository, the controlledcontent repository being securely and controllably accessed;establishing an access protocol for the controlled content repository,whereby approved content is stored in the controlled content repositoryaccording to the access protocol and whereby the access protocolcomprises at least one set of alignment rules for determining if a firstitem of approved content within the controlled content repository can bemade available to a first customer via an electronic message; storingthe approved content within the controlled content repository, theapproved content further being accessible according to the establishedaccess protocol; aligning the approved content within the controlledcontent repository with information from an information managementsystem; and generating an electronic message according to theestablished access protocol. The electronic message responds to amedical inquiry.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present application and itsadvantages, reference is now made to the following description taken inconjunction with the accompanying drawings, in which like referencenumbers indicate like features.

FIG. 1 illustrates an exemplary architecture for managing the buildingand sending of approved electronic communications;

FIG. 2 illustrates an example architecture for the content repository ofFIG. 1 in which content is built and organized in a controlled mannerthat facilitates efficient content generation;

FIG. 3 a illustrates a screenshot showing one embodiment of the “MyAccounts” option where the user may access personalized customer mailinglists;

FIG. 3 b illustrates a screenshot showing an embodiment of starting tobuild an approved email from a content page;

FIG. 4 illustrates a screenshot showing one example of the “EmailTargets” option in the mobile application (or web application) fromwhich users may select individuals from the mailing list as recipientsof an approved email;

FIG. 5 illustrates a screenshot of an example “Email Targets” screenwith individual email targets selected to receive an approved email;

FIG. 6 illustrates a screenshot of one embodiment of an “Email Template”selection screen where the user may choose one or more customer-alignedtemplates to generate approved emails to selected customers;

FIG. 7 illustrates a screenshot of an example approved template foremail generation with an example warning icon indicating that one ormore of the email recipients is unapproved to receive the content withinthe template or content attached to the template email;

FIG. 8 illustrates a screenshot of example pop-up screen detailing thereasons why individual customers may not be approved to receive thecontent;

FIG. 9 illustrates a screenshot of one embodiment of the signaturecapture technology available to users through the mobile application toprovide for remote opt-in for electronic communications;

FIGS. 10 a-c illustrate screenshots of an example approved emailtemplate with user-selected hyperlinks to approved content includedwithin the body;

FIG. 11 illustrates a screenshot of an example “Preview” screen, fromwhich the user may view the approved email in the format in which it isviewable by the recipient;

FIG. 12 illustrates a screenshot of an example customer portal throughwhich customers may access approved content from the controlled contentrepository;

FIGS. 13 a-b illustrate screenshots of one embodiment of the customerprofile information screen wherein users may have access to informationregarding approved email communication history with the customer;

FIG. 14 is a flowchart illustrating the providing and/or provisioning ofan approved email system;

FIG. 15 is a flowchart illustrating the building and sending of approvedemails;

FIGS. 16 a-b illustrate a flowchart of a method for building and sendingof an approved email in response to a medical inquiry;

FIG. 17 illustrates a screenshot of an example user interface fordisplaying a medical inquiry; and

FIG. 18 illustrates a screenshot of an example approved email inresponse to a medical inquiry.

Although similar reference numbers may be used to refer to similarelements for convenience, it can be appreciated that each of the variousexample embodiments may be considered to be distinct variations.

The present embodiments will now be described hereinafter with referenceto the accompanying drawings, which form a part hereof, and whichillustrate example embodiments which may be practiced. As used in thedisclosures and the appended claims, the terms “embodiment” and “exampleembodiment” do not necessarily refer to a single embodiment, although itmay, and various example embodiments may be readily combined andinterchanged, without departing from the scope or spirit of the presentembodiments. Furthermore, the terminology as used herein is for thepurpose of describing example embodiments only, and are not intended tobe limitations. In this respect, as used herein, the term “in” mayinclude “in” and “on,” and the terms “a,” “an” and “the” may includesingular and plural references. Furthermore, as used herein, the term“by” may also mean “from,” depending on the context. Furthermore, asused herein, the term “if” may also mean “when” or “upon,” depending onthe context. Furthermore, as used herein, the words “and/or” may referto and encompass any and all possible combinations of one or more of theassociated listed items.

DETAILED DESCRIPTION

Embodiments disclosed in the present application allow for control ofemail content for communications between system users and emailrecipients (customers) by providing for a system and method forgenerating an “approved email” communication. Users may access a list ofemail templates which have been pre-generated with approved content andthen aligned with various customer attributes such as regulatorylimitations, customer preferences and demographic information in orderto ensure compliant and tailored communication between the user and thecustomer.

Such controlled email or other electronic communication generationoccurs at an interface between a repository of approved content itemsand templates along with customer relationship management (CRM)information including customer profile information and parametersincluding customer preferences and regulatory limitations or fields thatcan be used to facilitate compliance with regulatory limitations. Thesystem is capable of generating warning notices to users when contentand customer access do not align and users may choose various actions toaddress the warning notices such as excluding certain customers from thecommunication or changing email content. The customer information isfrom a customer relationship management subsystem.

In disclosed embodiments, intelligent and flexible updating of recordsmay be provided within the customer relationship management subsystem,including such approaches as communicating with third-party systems andsources in order to verify and update customer information in aneffective and timely manner, such as by using the collective informationgained by managing a cloud-based system/Software-as-a-Service (SaaS)system on behalf of multiple company customers for the disclosedembodiments.

After approved emails are constructed by the user, the content containedwithin the approved email may be once again checked for accuracy andvalidity by the system before release to the email server. When acustomer accesses content within an approved email, the customer isdirected to a customer portal through which the content is accessed. Thecustomer may be only allowed access to the most current version of theapproved content within the content repository. In this manner, thecontent received and viewable by the customer has been verified inreal-time as being compliant, approved content.

FIG. 1 is a system overview illustrating an embodiment of a controlledemail communication system 100. The presently disclosed embodimentcomprises a controlled content repository 102, a Customer RelationshipManagement (CRM) server 106, and a multichannel processing engine 108.The customer relationship management server 106 may provide access to acustomer relationship management subsystem 104, and the multichannelprocessing engine 108 may be coupled to an email server 114. In oneembodiment, the customer relationship management subsystem 104 and/orthe email server 114 may be operated by a third party. The multichannelprocessing engine 108 may be accessed by users such as company salesrepresentatives through web clients 110 or through mobile apps 112 (suchas iOS, Android, Blackberry, or Windows Mobile systems), communicatingwith the multichannel processing engine 108 through web servers 113.Although the users may be described in the present application as beingcompany sales representatives, this particular described embodiment isnot intended to limit the generality of the claims that may eventuallyissue in patents stemming from the present disclosure.

The controlled content repository 102 is designed to have a process fordeveloping approved content that is sharable across multiple users, suchas shareholders, reviewers, managers, marketing personnel, salesrepresentatives, etc. The content generated in the controlled contentrepository 102 may be accessed on a regulated basis and used to generateapproved electronic communications. This regulated basis may bedetermined, in part, by the company as a whole and additionally byinteraction with data from the customer relationship managementsubsystem 104, described in further detail below. In one embodiment,approved content, customer profile information, customer preferences,and regulatory limitations and requirements may be stored in a table inthe controlled content repository 102. In addition to storage anddevelopment of content, the controlled content repository 102 may alsostore an audit trail, tracking exact content of communications as theywere sent by the user, as well as metadata about the communications andinformation regarding the content accessed by customers.

The customer relationship management subsystem 104 contains all contactinformation that may be available to users. In addition to storage ofcontact information, the customer relationship management subsystem 104may also be capable of storing configurations regarding specificpreferences, regulatory limitations and requirements, and other fieldsthat will facilitate the generation of appropriate approved electroniccommunications, in general or on a by-recipient basis. These preferencesand/or requirements include both the preferences of the user (e.g.,maintaining account lists) as well as the preferences of the enterprise(e.g., employers of the users), discussed in further detail below. Insome examples, the approved content and email templates may bepre-processed and stored in the controlled content repository 102 andprovided to the multichannel processing engine 108 during the processfor generating an approved email. In other examples, the customerrelationship management subsystem 104 may have a content managementsubsystem and may provide the approved content and the templates.

In this embodiment, the customer relationship management subsystem 104is capable of communication with multiple sources through the customerrelationship management server 106 or through other channels to maintaina current and accurate collection of information regarding customeraccounts. The interface with the multiple sources can be, for example,through an Applications Programming Interface or API, as the APIinterface will allow compatibility with a flexible array of third-partyprovider servers. The information being updated may include, but is notlimited to, licensing information, area of practice, and location of thevarious customer contacts. In this manner, the customer relationshipmanagement subsystem 104 pulls the approved version of what representsan account or physician, which then pulls from multiple networks toensure that the information regarding an account is up-to-date. Thecustomer relationship management subsystem 104 may also be used todetermine the type of domain an email communication is deliveredthrough. A customer in Spain may receive an email from “CompanyX.es,”whereas a customer in Germany would receive the same email from“CompanyX.ge.” This may allow for additional branding options for thecompany controlling and sending the electronic communications.

With further reference to the customer relationship management subsystem104, this system may be a cloud-based customer database that provides acentral access to store and distribute consistent data across customercompanies as well as their possible third-party partners and agenciesthat are used to keep this data updated. This system can providestandard data formats and provide an easy and automated way forcustomers to have access to coordinated and frequently updated CRM dataand to use that coordinated data for sending approved electroniccommunications in accordance with the system described herein.

In an embodiment, the multichannel processing engine 108 is responsiblefor combining the customer account information from the customerrelationship management subsystem 104 with content available from thecontrolled content repository 102. Within the customer relationshipmanagement subsystem 104, customer accounts may be assigned a set ofalignment rules which determine specific pieces of content that areavailable for use from the controlled content repository 102. Themultichannel processing engine 108 may apply these rules and supply theuser with a list of approved email templates and pieces of content thatmay then be used to construct an approved email communication. Approvedemail generation occurs within the multichannel processing engine 108according to executable code computer instructions stored in executablecode storage 120.

The executable code comprises computer readable instructions stored onthe computer readable medium (the code storage medium 120). Theexecutable code storage 120 is in communication with the variouscomputing machines in the system 100 such as the customer relationshipmanagement server 106 and the multichannel processing engine 108. Thesame or another executable code storage 120 may be accessed by thepreviously described components of the controlled content repository 102for providing separate computer readable code for operating upon byprocessing machines in that system. In all cases, the code is programmedto perform the functions that are described in the present embodimentsand/or additional functions according to system design needs.

Communication between the multichannel processing engine 108 and thecustomer relationship management subsystem 104 may occur via thecustomer relationship management server 106, which acts as an interfacebetween the two. The customer relationship management server 106 may actsolely as an entry and exit point for the customer relationshipmanagement subsystem 104. The user may access the multichannelprocessing engine 108 through either a Web Client 110 or through themobile apps 112 (such as iOS, Android, Blackberry, or Windows Mobilesystems).

FIG. 2 provides a description of the controlled content repository 102with additional specific applications and interfaces connected thereto.In an embodiment, this controlled content repository 102 is acloud-based or distributed network based system for consolidating anenterprise's data, oftentimes integrating multiple content repositoriesin an enterprise into a single system having coordinated control,measuring, and auditing of data creation, access and distribution.

In an embodiment of the controlled content repository 102 for the lifesciences industry, as illustrated in the figure, this repository 102 caninclude specific data collections for the following areas and/orbusiness process-specific front-end applications 204:

The Research & Development (R&D) front end application 208 provides foran aggregation of materials in support of research and initial clinicaltrial submissions through building organized and controlled contentrepositories within the controlled content repository 102. Elements thatcan be stored, organized, and managed through this front end includesubmission bills of materials, Drug Information Association (DIA)reference models support, and submission-ready renderings. This frontend 208 is designed to provide an interface to the controlled contentrepository 102 whereby researchers, contract research organizations(CROs), and other collaboration partners can access and/or distributecontent through a single controlled document system.

The clinical trials front-end application 210 provides for faster andmore organized access to trial documents and reports, while supportingseamless collaboration between sponsors, CROs, sites, investigators andother trial participants. Specific features both ease study and siteadministration as well as support the DIA trial master file (TMF)reference model. Having this front-end application providing access tothe controlled content repository 102 further provides for efficientpassing off of controlled content repository content between this phaseand other phases of the life sciences development process.

The manufacturing and quality application 212 enables the creation,review, approval and distribution of controlled documents across theorganization and with external partners in the context of materialscontrol and other manufacturing elements. The application 212 providesfunctionality in support of the manufacturing process includingwatermarking, controlled print, signature manifestation and “Read andUnderstood” signature capabilities. The documents and metadataassociated with this process is managed and stored in the controlledcontent repository 102 whereby it can be assured that the relateddocuments are not distributed in contravention of law and companypolicy.

The medical communications application 214 provides for communicationswith medical facilities, including call center access, integration, andinterface functionality. Particular access control features and metadataassociated with this application 214 include expiration and periodicreview elements, multi-channel support, global documents and automaticresponse package generation through the controlled content repository102.

The marketing and sales application 216 provides an end-to-end solutionfor the development, approval, distribution, expiration and withdrawalof promotional materials. Specific features include support for globalpieces, approved Form FDA 2253 (or similar international forms) formgeneration, online document, and video annotation, and a built-indigital asset library (DAL). Again, the communications may be throughthe controlled content repository 102.

In disclosed embodiments, there are provided a number of back-end systemapplications 220 that provide for the management of the data, forms, andother communications in the controlled content repository. For example,the back-end systems applications 220 may include a regulatorycompliance engine 222 to facilitate regulatory compliance, includingaudit trail systems, electronic signatures systems, and systemtraceability to comply with government regulations, such as 21 CFR Part11, Annex 11 and GxP-related requirements. The regulatory complianceengine 222 may include processors for developing metadata surroundingdocument and project folder accesses so from a regulatory compliancestandpoint it can be assured that only allowed accesses have beenpermitted. The regulatory compliance engine 122 may further includesprevalidation functionality to build controlled content in support ofinstallation qualification (IQ) and/or operational qualification (OQ),resulting in significant savings to customers for their systemvalidation costs.

In further disclosed embodiments, the back-end systems 220 may contain areporting engine 224 that reports on documents, their properties and thecomplete audit trail of changes. These simple-to-navigate reports showend users and management how content moves through its life cycle overtime, enabling the ability to track ‘plan versus actual’ and identifyprocess bottlenecks. The reporting engine may include processors fordeveloping and reporting life cycle and document management reportingbased on stored project data and access metadata relative to documents,forms and other communications stored in the controlled contentrepository 102.

In further disclosed embodiments, the back-end systems 220 can includean administrative portal 226 whereby administrators can controldocuments, properties, users, security, workflow and reporting with asimple, point-and-click web interface. Customers also have the abilityto quickly change and extend the applications or create brand newapplications, including without writing additional software code.

In further disclosed embodiments, the back-end systems 220 may include asearch engine 228 whereby the controlled content repository 102 candeliver simple, relevant and secure searching.

In providing this holistic combination of front-end applications 204 andback-end system applications 220, the various applications can furtherbe coordinated and communicated with by the service gateway 230, whichin turn can provide for communications with various web servers and/orweb services APIs 113. Such web servers and/or web services APIs 113 caninclude access to the content and metadata layers of some or all of thevarious applications 204 and systems 220, enabling seamless integrationamong complementary systems.

In the context of the described embodiments, the particular features andcapabilities integrate with the other elements of the controlled emailcommunication system 100 such that particular features are usable withinthe various user screens. For example, and without limitation to anyother possible combination of features, in the below-describeddescription of generating an approved electronic communication, theabove-described search portal can be used to search for approvedattachments (i.e. content) within the controlled content repository 102which may be then attached to one of the template emails being preparedfor sending to a customer. And the synergy of combining these particularsystems is that the generation of the controlled content can be done ina controlled fashion such that the approved content can be sent tocustomers with greater confidence in the integrity of the data beingsent.

FIG. 3 a illustrates an embodiment screenshot 302 of a “My Accounts”interface in a web-based or mobile interface within a web-based system110 or mobile system 112 (see FIG. 1). From this screen 302, a user mayselect an individual account from a list of existing physician or otherclinical accounts within the customer relationship management subsystem104. By selecting a specific individual account from the “My Accounts”screen 302, the user can be taken to a screen containing current contactinformation for the selected account as stored in the customerrelationship management subsystem 104. From this screen, users may beginconstructing an approved email to the individual customers by selectinga “Compose Email” link on the screen. In this embodiment, there areadditional options within the web-based or mobile application 110, 112for sending an individual customer an approved email. From the “MyAccounts” screen 302 shown in FIG. 3 a, the user may also click on ormouse over the “Action” sheet shown in this embodiment to the right ofthe contact name to get a pop-up window and select a “Send Email” link310 in the pop-up window. The user may click on a link 305 to updateinformation of the accounts.

A user may also begin constructing an email from a content page, e.g.,when the user is viewing a document or a video on his screen. FIG. 3 billustrates an embodiment screenshot 352 of a “Call Report” interface ina web-based or mobile interface within a web-based system 110 or mobilesystem 112 (see FIG. 1). While viewing a Call Report 360 on screen 352,a user may decide to send content related to some topics in the CallReport. The user may click on or mouse over the “Action” sheet next tothe “Sign” link shown in this embodiment to get a pop-up window and thenselect a “Send Email” link 355 in the pop-up window. After that, thescreenshot 302 may be displayed for the user to build an approved email.Because the described system including the controlled content repository102 provides for a coherent and controlled access to the approvedcontent for email communications, it can be made quite flexible as toproviding consistently formatted and approved content from variousapplications and/or specific screenshots within applications.

Referring now to FIG. 4, by selecting the “Account Lists” 320 on theleft hand side of the screen in FIG. 3 a, users may access personally orinstitutionally pre-constructed lists 410 of individual customers asconfigured in the customer relationship management subsystem 104. Fromthis screen 402, the user may also select a number of individualcustomer accounts 420 with whom they wish to communicate. Once desiredcustomers have been selected from the list, which could include theselecting of all customers in the list, the user may begin building anapproved email to the selected customers through the web-based or mobileclient application 110, 112. The email may be constructed within themultichannel processing engine 108 from the accessible content providedby the controlled content repository 102 which has been aligned with thecustomer information provided by the customer relationship managementsubsystem 104.

FIG. 5 illustrates an exemplary screenshot 502 in which the user beginsconstructing the approved email by selecting an “Email Targets” link505. The link icon may also contain the number of selected customers inparentheses. In this embodiment, the “Send Email” links 510 appear afterthe customer selection of the “Email Targets” link 505.

Shown in FIG. 6, by selecting the “Send Email” link, the user may accessthe “Email Generation Wizard.” From this screen 602, a user may accesspre-approved, controlled email templates 604 that are available andapproved for the specific group of customers selected. From thisapproved list, the user may select multiple templates. After desiredtemplates are selected, individual tabs appear at the top of the screenand within each tab is a separate approved email which may be sent tothe selected customers.

The user may access an individual template, as shown in the screenshot702 of FIG. 7, by selecting the appropriate tab 710. The template mayalso display a warning icon 720, shown in the top left of FIG. 7, whichindicates that one or more of the selected individuals may be restrictedfrom receiving the chosen template with its current content. Thiswarning is generated from information contained within the customerrelationship management subsystem 104. The user may select this icon720, which generates a pop-up window 802 containing specific warninginformation for all potential recipients who may be currently restrictedfrom receiving the content, shown in FIG. 8. Recipients may be removedfrom the email list on this screen by selecting the appropriate icon.

Warnings generated on the pop-up screen 802 illustrated in FIG. 8 mayappear for reasons that include, but are not limited to, regulatorylimitations, customer preferences, demographic information, a customer“opt-out” option where the customer has requested to not have thecontent delivered; the absence of a customer “opt-in” option where thecustomer may not receive the communication without prior approval; orthat the most current information contained within the customer accountprofile no longer allows access to the current content delivered by thecontrolled content repository 102. Information regarding regulatorylimitations, customer preferences, demographic information, the “opt-in”or “opt-out” status of individual customer accounts is stored within thecustomer relationship management subsystem 104.

In an embodiment, as shown in FIG. 9, the user may access an “opt-in”request 902 from the recipient of the email through the web-based ormobile client applications 110, 112. In this embodiment, the user mayhave access to signature capture technology, which allows for instant,remote customer approval along with the appropriate signature 905.

Once all warnings are cleared, or all restricted recipients are removedfrom the list, the user may once again have access to the approved emailtemplate 1002 as illustrated in FIG. 10 a. Email templates may be either“branded” with imagery 1003 or may be presented in a plain, text-onlyformat, selectable by the user. As illustrated in FIG. 10 a, the usermay have the ability to personalize the email content by free-texting inthe text box 1004 supplied within the template. This customizable textbox 1004 may also be regulated to ensure compliance by limiting thenumber of characters that may be typed in the box and by constructing“libraries” of restricted words for each customer that may not be usedin the box. The information used to regulate the text box may beaccessed from the customer relationship management subsystem 104, andconfiguration of these regulatory parameters may be designated by boththe company, by the specific customer, and/or by specific regulation.Within the approved template, the user may choose from approved contentto be included in the body of the email.

The user may select the “Select Documents to Share” icon 1010 within thetemplate, which generates a pop-up screen 1020 (see FIG. 10 b)containing a list of approved content from within the controlled contentrepository 102 that has been aligned with the customer informationretrieved from the customer relationship management subsystem 104. Fromthe pop-up screen 1020, the user may select multiple content items to beincluded within the body in the form of one hyperlink per selectedcontent item. As the content items are selected, they are added to thebody of the email as individual tiles 1030 as illustrated in the centerof FIG. 10 b. The list of content items may be rearranged by the user bydragging the tiles into the desired order. The user may preview theapproved email on the web-based or mobile applications 110, 112 as itwill be received by the customer by selecting the “magnifying glass”icon 1040 located within the template screen. The user may then returnto the edit function by selecting an “editing” icon or clicking outsidethe document selection pop-up screen 1020.

From this continued editing screen 1050 of FIG. 10 c, the user may alsoselect a customized valediction from a drop-down menu located within thetemplate 1050. The overall approved content authoring system describedherein includes selection capabilities that are highly flexible, highlyconfigurable, and may be applicable to any place within the approvedemail template. The user may then send the email to selected recipientsusing the “Send” icon 1060 illustrated in FIG. 10 c.

The communications between the mobile applications 112 or the webclients 110 and the multichannel processing engine 108 may use anycommunication protocols between a web client and its server, e.g.,HttpPost.

In one embodiment, the content contained within the generated email maybe once again checked for accuracy and validity by the system justbefore releasing. Once the approved email is generated in themultichannel processing engine 108 and the user selects the “Send” icon,the communication is then sent to the controlled content repository 102for final verification of the accuracy and validity of the selectedcontent. The controlled content repository 102 may also store audittrail data 150 which documents and retains information that may include,but is not limited to, recipient information, time stamp data, and themost current version number of any content included within the approvedemail. The communication is then sent back to the multichannelprocessing engine 108, where it may be routed through an email server114 and then delivered to the customer's preferred inbox. Themultichannel processing engine 108 may send only enough information tothe email server 114 for the email server 114 to create an email, andthe email server 114 may create the actual email to be sent to thecustomer. The email server 114 may collect and distribute the outboundemail content, but it may also collect interaction information from thecustomer regarding clicks, views, and other statistics regardingcustomer usage. As shown in FIG. 1, this information may then be postedback to the multichannel processing engine 108 as CRM updates 111 andsent through the customer relationship management server 106 to bedeposited in the customer relationship management subsystem 104 asinformation contained within the customer account profile. The emailsent may also be stored in the customer relationship managementsubsystem 104.

As shown in the approved email preview screen 1102 illustrated in FIG.11, when an approved email is opened by the customer, the customer mayhave immediate access to communications as they appeared in the“preview” screens or thumbnails available to the user through theweb-based or mobile applications 112. This communication 1102 includesthe readable text and a tiled list of approved content hyperlinks, shownin the figure. The recipient may choose to view the content by selectingthe appropriate content icon. In an embodiment of the system, therecipient may select the “view pdf” hyperlink 1110 within the email,which will redirect the recipient to the customer portal screen 1202,shown in FIG. 12. Each recipient has the ability to custom-configure thespecific URL to be loaded as the “landing page” for clicks from theapproved emails.

This arrangement allows for the direction of customers to specificportals. Within the portal 1202, the recipient may view the full text ofthe content that was included as a tile within the body of the originalapproved email. The content is accessed directly from the controlledcontent repository 102 to ensure that the most up-to-date information isdisplayed when the customer accesses the selected content. If thecontent has been updated to a newer version since the user constructedthe approved email, then the hyperlink included in the approved emailwill automatically connect the customer to the most up-to-date versionof the selected content. Information regarding the content versionviewed by the customer may be stored with other pertinent informationabout the customer experience in the audit trail within the controlledcontent repository 102. In one embodiment, the controlled contentrepository 102 may create a token for the approved content to be sentwith the approved email. The token may have information about whichpiece of content to show to the customer, and direct the customer to theright content. In one embodiment, even when the content is updated afterthe email is sent, the token may direct the customer to the latestversion of the content.

Illustrated in FIG. 13 a-b is an embodiment of the system that allowsthe user access to information regarding specific communications. Thisinformation is stored in the customer relationship management subsystem104 along with customer account information. The user may access thisinformation through either mobile apps 112 or through web clients 110.The information available may include, but is not limited to, the numberof times the approved email communication has been opened by thecustomer, the number of clicks executed, type of device used to accessthe communication, platform used when accessing the content, andlocation when the communication was viewed.

FIG. 14 is a flowchart illustrating the building and/or provisioning ofexemplary elements of an approved email system in accordance with theembodiments disclosed in the present application. The method starts andblock 1400, after which the system builders and/or administratorsestablish a controlled content repository 102 at block 1402. Asdescribed herein, the controlled content repository is designed to besecurely and controllably accessed such that only authorized users canbuild the controlled content therein. To ensure the integrity andsecurity of the controlled content repository 102, an access protocol isestablished at block 1404. The access protocol may be defined bycomputer instructions stored in the computer readable memory orexecutable code storage 120. By the computer instructions storedtherein, the multichannel processing engine 108 is thereby able tocontrol access to the controlled content repository 108 in accordancewith the principles described in the present application.

At block 1406, one or more users establish approved content to be storedin the controlled content repository 102 under the control of the accessprotocol established at block 1404 (or as that protocol is later changedor updated). At block 1408, a system designer or other admin establishesor updates email templates that approved content senders can pick andchoose from in building approved email content messages. At block 1410,a customer relationship management system is accessed such that theapproved emails can be addressed to customer contacts of the enterpriseor salesperson for the enterprise who is engaging in the marketing,manufacturing, clinical trials, or other activity described herein. Atblock 1412, the actual email generation system is provided thatinterfaces with the approved content, the access protocol, the emailtemplates, and/or the customer relationship management system. Thisemail generation system, or more specifically the multichannelprocessing engine 108, is accessed by senders of approved email contentas described in the present application.

It should be appreciated that as previously discussed, the customerrelationship management system 104/106 may be further operable tocommunicate with multiple sources of information to build a current andaccurate collection of information regarding customer accounts. Itshould also be appreciated that to facilitate such communications, atleast one of the multiple sources of information that might communicatewith the custom relationship management system 104/106 may communicatewith external servers that belong to one or more third-party partners oragencies through an Application Programming Interface (“API”) wherebythe customer relationship management system can flexibly receive dataupdates from the one or more third-party partners or agencies. Theaccess protocol that is established may also include a set of alignmentrules that determine specific pieces of approved content that areavailable to the selected customers from the controlled contentrepository.

While FIG. 14 is described in basic terms regarding its generaloperation as a controlled content access system, it should beappreciated that such a system is described herein with multiplespecific implementations. Such specific implementations can befacilitated through front-end applications in the context of supportingresearch, development, and initial clinical trial submissions aspreviously described. Other front-end applications as previouslydescribed include manage access and/or distribution of trial documentsand reports in support of ongoing clinical trials, materials controland/or manufacturing process controls, communications with medicalfacilities in support of medical facility operations, and thedevelopment and distribution of promotional materials as related toregulatory restricted products such as prescription drugs.

To facilitate the compliance with government regulation, a regulatorycompliance engine can be provided to review content and the accessprotocols and to ensure that only approved content authored by properlyauthorized individuals and according to required controls can bedistributed to permitted possible customers or other content recipientsin accordance with government regulations.

Next with regard to FIG. 15, a method for generation of approved emailcontent is described. In particular, FIG. 15 shows at block 1500 thestart of the process, after which at block 1502 an email author orprospective sender can choose a template from a set of customizabletemplates. In this way the email authors or prospective senders do nothave to recreate content every time an email campaign is beginning. Atblock 1504, the user selects the desired content from the approvedcontent repository 102, and the user at block 1506 selects the desiredrecipients or customers from the CRM database 104.

Still referring to FIG. 15, the system, or more specifically themultichannel processing engine 108 confirms that the approved contentand form of email may permissibly be sent by the prospective emailsender to the customers or other selected recipients at 1508 based onfactors including but not limited to regulatory limitations, customerpreferences, demographic information, or the “opt-in” or “opt-out”status of individual customer accounts. Once that has been confirmed inaccordance with the access protocol, the multichannel processing engine108 can begin building and sending the emails in accordance with theuser's selections or as modified in accordance with the access protocol,regulator engine, and or other system controls, at 1512. The contentcontained within the approved email may be checked for accuracy andvalidity by the system before release to the email server 114. If theemail is created when the user is offline, the content contained in theapproved emails may be checked again after the user is back online,before they are sent to the email server.

The approved email may be initiated in other scenarios. In oneimplementation, the approved email may be used to answer a medicalinquiry.

FIGS. 16 a-b illustrate a flowchart of a method for building and sendingof an approved email in response to a medical inquiry, and FIGS. 17-18illustrate examples of user interfaces during the process.

The process may start at 1600.

At 1602, a medical inquiry may be received by a sales representativeduring his meeting with a physician. The physician may ask if theproduct ColdCap can be used by the university in an upcoming study.Since the sales representative is not authorized to answer medicalinquiries, he may create a medical inquiry record in the customerrelationship management subsystem 104, e.g., medical inquiry 0678 shownin FIG. 17, to document the medical inquiry. The medical inquiry recordmay capture the question from the physician pertaining to a medicaltopic in a structured way, and may include fields such as the medicalinquiry ID, the physician's account information, the physician'spreference information, the product involved, the inquiry text, thesales representative receiving it, and the time it was received. Themedical inquiry may be received in other scenarios, e.g., by a customerservice representative via an email, by a call center agent via a call,or from helpdesk. A record may be created for each medical inquiryreceived, and all communications related to the medical inquiry mayreference that record when they are created and documented, e.g., via alook up field.

At 1604, the sales representative may send an approved email to thephysician to acknowledge receipt of the medical inquiry. In oneimplementation, when the sales representative submits a medical inquiryrecord, a pop-up window may be displayed, asking the salesrepresentative if he wants to acknowledge receipt of the medical inquiryvia an approved email. If the sales representative says yes, an approvedemail may be generated and displayed. In one embodiment, theacknowledgement may be generated with the method shown in FIG. 15. Thetemplate may automatically reference data points from the medicalinquiry record, e.g., name of the sales representative, name of thephysician, email address of the physician, the time the medical inquirywas received, the medical inquiry ID, and the inquiry text. The salesrepresentative may send the acknowledgement to the physician, and thecustomer relationship management subsystem 104 may be updated todocument that the acknowledgement has been sent.

At 1606, the medical inquiry may be routed to a medical liaison. In oneimplementation, the medical inquiry may be sent to the medical liaisonin an email. Alternatively, the medical liaison may access the medicalinquiry in the customer relationship management subsystem 104 andrespond with an approved email directly. The medical liaison may be amember on the manufacturer's medical team, and trained and qualified toanswer certain medical questions. The medical liaison may have morefreedom to write free text than sales representatives in the email. Themedical liaison's profile may indicate that he is qualified to answermedical inquiries, authorized to use free text approved email, and canbe provided with a template for free text approved email.

At 1608, a user input may be received indicating that the medicalliaison wants to respond to the medical inquiry directly from themedical inquiry page 1700 with an approved email, e.g., a click on a“Send Email” link 1701 on page 1700.

At 1610, it may be determined, e.g., by the customer relationshipmanagement subsystem 104, if the medical liaison is authorized torespond to the medical inquiry based on regulatory limitations and/orhis profile information. If not, the process may return to 1600.

If the medical liaison is authorized to respond to the medical inquire,at 1612, a set of customizable templates may be displayed for him tochoose from, and at least one of the templates is for a free textapproved email. As shown in FIG. 18, the template 1800 may have one ormore fields referencing the medical inquiry, e.g., medical inquiry ID,name of the sales representative, name of the physician, the time themedical inquiry was received, and/or the inquiry text, and these fieldsmay be automatically filled with data pulled from the medical inquiryrecord when the template is generated, e.g., “000678”, “Bob Sales”,“Jane Doe”, “12/1/2014”, and “if the university can use ColdCap in anuncoming study”.

The template 1800 may include a free text window 1801 for the medicalliaison to enter free text to respond to the medical inquiry. In oneimplementation, the free text window 1801 may allow the medical liaisonto enter free text in plain text or rich text format.

At 1614, free text responding to the medical inquiry may be received atthe free text window 1801.

At 1616, the user may select desired content from the approved contentrepository 102 and embed its link 1802 in the free text approved email,as shown in FIG. 18. The desired content may be, e.g., productinformation or safety message.

At 1618, in response, the system, or more specifically the multichannelprocessing engine 108, may determine if the free text approved email,including the selected content, may permissibly be sent by the medicalliaison to the physician based on factors including but not limited tokeyword check, regulatory limitations, customer preferences, demographicinformation, or the “opt-in” or “opt-out” status of individual customeraccounts. The keyword check may determine if the free text approvedemail includes any words which are unapproved and need to be blocked,e.g., those wrong, misleading, derogatory, illegal, or offensive. In oneimplementation, a filter may be used for the keyword checking.

If it is not permissible to send the email by the medical liaison to thephysician, the medical liaison may be informed so that he can revise theemail and/or change the content.

Once it is determined that the free text approved email can be sent tothe physician, the multichannel processing engine 108 can send it at1620. The content contained within the free text approved email may bechecked for accuracy and validity by the system before release to theemail server 114. If the email is created when the medical liaison isoffline, the content contained in the email may be checked again afterhe is back online, before the email is sent to the communication server114.

At 1622, the email sent may be stored in the controlled contentrepository 102, more specifically, the audit trail storage 150.Alternatively, the email sent may be stored in the customer relationshipmanagement subsystem 104

At 1624, the customer relationship management subsystem 104 may beupdated, via the CRM updates 111, to record that the email from themedical liaison has been answered.

The process may end at 1630.

Consequently, all communications related to the medical inquiry may bewell preserved, because the medical inquiry record is created in thecustomer relationship management subsystem 104, emails related to themedical inquiry reference the medical inquiry record, the emails arelogically linked to the medical inquiry and documented in the CRMsystem.

The flowcharts do not mean to limit the sequence of the steps. In oneexample, the controlled content repository 102 may determine in advance,before a template is chosen at 1502, if a piece of content can be sentto a customer and store the result. The result may be stored as a partof metadata for the content in the controlled content repository 102.During the generation of the approved email, the multichannel processingengine may check information in the controlled content repository 102,instead of the customer relationship management subsystem 104, to decideif a piece of content can be sent to a customer.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Thus, the breadth and scope of a preferred embodiment shouldnot be limited by any of the above described exemplary embodiments, butshould be defined only in accordance with the claims and theirequivalents for any patent that issues claiming priority from thepresent provisional patent application.

For example, although the embodiments are described with a customerrelationship management subsystem 104, the customer information andcontent may be from other types of information management systems, e.g.,a Closed Loop Marketing (CLM) system. In addition, the multichannelprocessing engine 108 is shown to communicate with only one customerrelationship management subsystem 104 in the drawings, but it maycommunicate with more customer relationship management subsystems. Forexample, as referred to herein, a machine or engine may be a virtualmachine, computer, node, instance, host, or machine in a networkedcomputing environment. Also as referred to herein, a networked computingenvironment is a collection of machines connected by communicationchannels that facilitate communications between machines and allow formachines to share resources. Network may also refer to a communicationmedium between processes on the same machine. Also as referred toherein, a server is a machine deployed to execute a program operating asa socket listener and may include software instances.

In all descriptions of “servers” or other computing devices herein,whether or not the illustrations of those servers or other computingdevices similarly show a server-like illustration in the figures, itshould be understood that any such described servers or computingdevices will similarly perform their described functions in accordancewith computer-readable instructions stored on a computer-readable mediathat are connected thereto.

Resources may encompass any types of resources for running instancesincluding hardware (such as servers, clients, mainframe computers,networks, network storage, data sources, memory, central processing unittime, scientific instruments, and other computing devices), as well assoftware, software licenses, available network services, and othernon-hardware resources, or a combination thereof.

A networked computing environment may include, but is not limited to,computing grid systems, distributed computing environments, cloudcomputing environment, etc. Such networked computing environmentsinclude hardware and software infrastructures configured to form avirtual organization comprised of multiple resources which may be ingeographically disperse locations.

The approved content may be in any format, e.g., text, audio, video,picture, multimedia, or PDF.

Various terms used herein have special meanings within the presenttechnical field. Whether a particular term should be construed as such a“term of art,” depends on the context in which that term is used.“Connected to,” “in communication with,” or other similar terms shouldgenerally be construed broadly to include situations both wherecommunications and connections are direct between referenced elements orthrough one or more intermediaries between the referenced elements,including through the Internet or some other communicating network.“Network,” “system,” “environment,” and other similar terms generallyrefer to networked computing systems that embody one or more aspects ofthe present disclosure. These and other terms are to be construed inlight of the context in which they are used in the present disclosureand as those terms would be understood by one of ordinary skill in theart would understand those terms in the disclosed context. The abovedefinitions are not exclusive of other meanings that might be impartedto those terms based on the disclosed context.

Words of comparison, measurement, and timing such as “at the time,”“equivalent,” “during,” “complete,” and the like should be understood tomean “substantially at the time,” “substantially equivalent,”“substantially during,” “substantially complete,” etc., where“substantially” means that such comparisons, measurements, and timingsare practicable to accomplish the implicitly or expressly stated desiredresult.

Additionally, the section headings herein are provided for consistencywith the suggestions under 37 CFR 1.77 or otherwise to provideorganizational cues. These headings shall not limit or characterize theinvention(s) set out in any claims that may issue from this disclosure.Specifically and by way of example, although the headings refer to a“Technical Field,” such claims should not be limited by the languagechosen under this heading to describe the so-called technical field.Further, a description of a technology in the “Background” is not to beconstrued as an admission that technology is prior art to anyinvention(s) in this disclosure. Neither is the “Brief Summary” to beconsidered as a characterization of the invention(s) set forth in issuedclaims. Furthermore, any reference in this disclosure to “invention” inthe singular should not be used to argue that there is only a singlepoint of novelty in this disclosure. Multiple inventions may be setforth according to the limitations of the multiple claims issuing fromthis disclosure, and such claims accordingly define the invention(s),and their equivalents, that are protected thereby. In all instances, thescope of such claims shall be considered on their own merits in light ofthis disclosure, but should not be constrained by the headings set forthherein.

What is claimed is:
 1. A machine-implemented method for generatingapproved electronic messages, the method comprising: establishing acontrolled content repository, the controlled content repository beingsecurely and controllably accessed; establishing an access protocol forthe controlled content repository, whereby approved content is stored inthe controlled content repository according to the access protocol andwhereby the access protocol comprises at least one set of alignmentrules for determining if a first item of approved content within thecontrolled content repository can be made available to a first customervia an electronic message; storing the approved content within thecontrolled content repository, the approved content further beingaccessible according to the established access protocol; aligning theapproved content within the controlled content repository withinformation from an information management system; and generating anelectronic message according to the established access protocol, whereinthe electronic message responds to a medical inquiry from the firstcustomer.
 2. The method of claim 1, wherein the information managementsystem is a customer relationship management (CRM) system or a closedloop marketing (CLM) system.
 3. The method of claim 1, furthercomprising: creating a record for the medical inquiry in the informationmanagement system.
 4. The method of claim 3, further comprising:enabling a sender to access the medical inquiry.
 5. The method of claim4, further comprising: displaying the medical inquiry on a userinterface, and receiving an input on the user interface for answeringthe medical inquiry with the electronic message.
 6. The method of claim5, further comprising: providing a template for the electronic message,wherein the template is pre-generated with data pulled from the recordfor the medical inquiry in the information management system.
 7. Themethod of claim 6, wherein the template has at least one customizablearea for receiving free text answering the medical inquiry.
 8. Themethod of claim 6, wherein the free text is in rich text format.
 9. Themethod of claim 6, further comprising: determining that the sender isauthorized to enter free text answering the medical inquiry to the atleast one customizable area by checking the sender's profileinformation.
 10. The method of claim 6, further comprising: receivingfree text answering the medical inquiry at the at least one customizablearea, and determining if the free text includes a first unapproved word.11. The method of claim 10, further comprising: blocking the electronicmessage and informing the sender if the free text includes the firstunapproved word.
 12. The method of claim 10, further comprising:filtering the free text for the first unapproved word.
 13. The method ofclaim 6, further comprising: determining if the electronic message maypermissibly be sent by the sender to the first customer according to alimitation in the information management system.
 14. The method of claim13, wherein the limitation in the information management systemcomprises a regulatory limitation, preferences of the first customer,and profile information of the first customer.
 15. The method of claim4, further comprising: sending the electronic message to the firstcustomer; and updating the information management system with thesending of the electronic message.
 16. The method of claim 1, whereinthe controlled content repository is adapted to provide development anddistribution of promotional materials as related to regulatoryrestricted products.
 17. The method of claim 16, wherein the regulatoryrestricted products are prescription drugs.
 18. A system for generatingapproved electronic messages, comprising: a controlled contentrepository for storing approved content according to an access protocol,wherein the access protocol is based on regulatory restrictions, andcomprises at least one set of alignment rules for determining if a firstpiece of approved content within the controlled content repository canbe made available to a first customer via an electronic message; aninformation management system for storing a record for a medical inquiryfrom the first customer; and an approved electronic message generator,coupled to the controlled content repository and the informationmanagement system, coupled to an application over a network, andgenerating an electronic message for answering the medical inquiry fromthe first customer, wherein the electronic message comprises data pulledfrom the record for the medical inquiry.
 19. The system of claim 18,further comprising: a keyword filter for determining if free text in theelectronic message includes a first unapproved word.
 20. The system ofclaim 18, further comprising: a regulatory compliance engine forchecking that the electronic message is in compliance with governmentregulations.